Reflexology: A randomised controlled trial investigating the effects on beta-endorphin, cortisol and pregnancy related stress.

Reflexology is used for various pregnancy related complaints. A three-armed, pilot randomised controlled trial was conducted to test changes in physiological and biochemical stress parameters. Ninety primiparous volunteers experiencing low back and/or pelvic girdle pain (LBPGP) were recruited to receive either six reflexology or footbath treatments or usual care. Primary outcome data included pain intensity and frequency measured on a visual analog scale (VAS), and salivary beta-endorphin and cortisol levels. 61 (68%) women completed the intervention. A clinically important reduction of 1.63 cm occurred for VAS pain frequency following reflexology. Beta-endorphin levels increased by 8.8% and 10.10% in the footbath and usual care groups respectively and decreased by 15.18% for the reflexology group. Cortisol increased by 31.78% for footbath participants, 31.42% in usual care and 18.82% in the reflexology group. Reflexology during pregnancy may help reduce LBPGP, and associated stress. However, antenatal reflexology is under researched and requires further investigation.

Factors Affecting Recruitment and Attrition in Randomised Controlled Trials of Complementary and Alternative Medicine for Pregnancy-Related Issues.

Background. Randomised controlled trials (RCTs) investigating Complementary and Alternative Medicine (CAM) for pregnancy-related issues have encountered issues with recruitment and attrition. Little is known about the cause of these issues. Methods. Data was gathered from an antenatal CAM randomised controlled trial. During foetal anomaly appointments, women meeting inclusion criteria were invited to participate in the trial. Numbers of women invited and eligible were recorded. Reasons for noninterest were noted and analysed. Focus groups exploring trial experience of participants were also conducted. Findings. Of the 428 women invited to participate, 376 were eligible and just under a quarter participated. Reasons for nonparticipation included concerns about CAM and lack of interest in participation in research. Other factors negatively affecting recruitment included recruitment timing, competition for participants, limited support from staff, and inadequate trial promotion. Factors encouraging recruitment included being interested in research and seeking pain relief. Reasons for dropping out were time constraints, travel issues, work commitments, and pregnancy issues. Several women in the sham and usual care group dropped out due to dissatisfaction with treatment allocation. Conclusion. CAM researchers must explore problems encountered with recruitment and attrition so that evidence-based implementation strategies to address the issues can be developed.

Exercise and Auricular Acupuncture for Chronic Low-back Pain: A Feasibility Randomized-controlled Trial.

OBJECTIVES: To evaluate the feasibility of a randomized-controlled trial (RCT) investigating the effects of adding auricular acupuncture (AA) to exercise for participants with chronic low-back pain (CLBP). METHODS: Participants with CLBP were recruited from primary care and a university population and were randomly allocated (n=51) to 1 of 2 groups: (1) "Exercise Alone (E)"-12-week program consisting of 6 weeks of supervised exercise followed by 6 weeks unsupervised exercise (n=27); or (2) "Exercise and AA (EAA)"-12-week exercise program and AA (n=24). Outcome measures were recorded at baseline, week 8, week 13, and 6 months. The primary outcome measure was the Oswestry Disability Questionnaire. RESULTS: Participants in the EAA group demonstrated a greater mean improvement of 10.7% points (95% confidence interval, -15.3,-5.7) (effect size=1.20) in the Oswestry Disability Questionnaire at 6 months compared with 6.7% points (95% confidence interval, -11.4,-1.9) in the E group (effect size=0.58). There was also a trend towards a greater mean improvement in quality of life, LBP intensity and bothersomeness, and fear-avoidance beliefs in the EAA group. The dropout rate for this trial was lower than anticipated (15% at 6 mo), adherence with exercise was similar (72% E; 65% EAA). Adverse effects for AA ranged from 1% to 14% of participants. DISCUSSION: Findings of this study showed that a main RCT is feasible and that 56 participants per group would need to be recruited, using multiple recruitment approaches. AA was safe and demonstrated additional benefits when combined with exercise for people with CLBP, which requires confirmation in a fully powered RCT.

Chronic low back pain: patients' experiences, opinions and expectations for clinical management.

PURPOSE: To explore the experiences, opinions and treatment expectations of chronic low back pain (LBP) patients in order to identify what components of treatment they consider as being of most value. METHOD: Three stand-alone focus groups were convened. All participants were experiencing chronic non-specific LBP (>3 months). Each group was facilitated by an independent moderator, and guided by a series of pre-determined questions. Participants were encouraged to freely air their personal opinions during the discussion. Transcribed data were organized into a series of 'categories' using the Qualitative Solutions for Researchers Nudist 6 package from which five common themes emerged. RESULTS: Each participant had typically experienced a variety of failed treatment approaches. Whilst the value of advice and exercise was recognized, participants typically questioned the appropriateness of such treatment given the fact that a precise diagnosis was rarely given, and symptoms often recurred. As a result, poor adherence with advice and exercise appeared to be a key factor limiting the potential effectiveness of long-term self-management strategies. CONCLUSIONS: Participants considered appropriate exercise (despite pain) and activity modification as important components for effective long-term self-management of symptoms. To enhance treatment effectiveness, participants welcomed the introduction of individually tailored advice and exercise programmes, with supervision and follow-up support, along with a better understanding of the physical and emotional impact of chronic LBP by practitioners.

Exercise and chronic low back pain: what works?

The aim of this review was to investigate current evidence for the type and quality of exercise being offered to chronic low back pain (CLBP) patients, within randomised controlled trials (RCTs), and to assess how treatment outcomes are being measured. A two-fold methodological approach was adopted: a methodological assessment identified RCTs of 'medium' or 'high' methodological quality. Exercise quality was subsequently assessed according to the predominant exercise used. Outcome measures were analysed based on current recommendations. Fifty-four relevant RCTs were identified, of which 51 were scored for methodological quality. Sixteen RCTs involving 1730 patients qualified for inclusion in this review based upon their methodological quality, and chronicity of symptoms; exercise had a positive effect in all 16 trials. Twelve out of 16 programmes incorporated strengthening exercise, of which 10 maintained their positive results at follow-up. Supervision and adequate compliance were common aspects of trials. A wide variety of outcome measures were used. Outcome measures did not adequately represent the guidelines for impairment, activity and participation, and impairment measures were over-represented at the expense of others. Despite the variety offered, exercise has a positive effect on CLBP patients, and results are largely maintained at follow-up. Strengthening is a common component of exercise programmes, however, the role of exercise co-interventions must not be overlooked. More high quality trials are needed to accurately assess the role of supervision and follow-up, together with the use of more appropriate outcome measures.